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NCT Number: NCT02770404

A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects

This is a Phase 1, randomized, double-blind, single-center, placebo-controlled, sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin or matching placebo on Day 1.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phase 1 unit : Spaulding Clinical Research, LLC

West Bend, Wisconsin, 53095, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subject between 18 and 55 years of age, both inclusive,
  • creatinine clearance ≥80 mL/minute (Cockcroft-Gault method).

Exclusion criteria

  • Clinically relevant pathology or any other systemic disorder/major surgeries that in the opinion of the investigator would confound the subject's participation and follow-up in the clinical study.
  • Drug or food allergy.

Treatment and study plan

Nafithromycin

Drug

100, 200, or 400 mg of nafithromycin

Placebo

Drug

IV matching placebo

Other names: Matching IV placebo

Primary outcomes

  1. Area under the plasma concentration-time curve

    Time frame: 72 hours from dosing

  2. Maximum observed plasma concentration (Cmax)

    Time frame: 72 hours from dosing

  3. Time to Cmax (Tmax)

    Time frame: 72 hours from dosing

Secondary outcomes

  1. clinical laboratory- Number of subjects with deranged heamatology parameters test results

    Time frame: 14 days

  2. 12-lead safety ECG results

    Time frame: 14 days

  3. Number of subjects reported with any local tolerability at the injection site assessments

    Time frame: 14 days

  4. Number of subjects with any abonormal physical examination findings

    Time frame: 14 days

  5. Total number of reported AEs

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Wockhardt

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 12, 2016
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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